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What is the intended purpose of the FREEDOM LASER THERAPY IRESTORE ID-500?
The FREEDOM LASER THERAPY IRESTORE ID-500 is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.
Under what conditions should the FREEDOM LASER THERAPY IRESTORE ID-500 not be used?
The FREEDOM LASER THERAPY IRESTORE ID-500 is contraindicated and should not be used in the following situations:
• Do not use the device if you are taking medications or if you have any medical condition which makes your skin sensitive to sun or light.
• Do not use the device if you have cancer on your scalp.
• Do not use the device if you have sensitive skin or if you are allergic to the specific wavelength of light (640-665nm). Sensitive skin or an allergic reaction can result in an itchy sensation of the scalp or sunburn-like redness. If these occur, seek medical care from a physician.
• The device should not be used by or on children under 18 years of age.
What are the warnings and precautions for using the FREEDOM LASER THERAPY IRESTORE ID-500?
Please observe the following warnings and precautions when using the FREEDOM LASER THERAPY IRESTORE ID-500:
• Do not look directly at, or use optical instruments like magnifiers or microscopes to look at, the laser light or its reflection off a mirror-like surface. The device contains Class 3R lasers that may cause harm to the retina and eye irritation if pointed directly at the eyes.
• Discontinue use if scalp itching or tingling occurs and lasts more than one (1) hour after a treatment session. If the problem continues, consult with a physician.
• Always unplug the device from the power outlet when not in use and never leave it unattended while plugged in.
• Do not put tension on the cord while handling, untangling, or straightening it, as this may break the cord.
• Do not get the device or adapter wet to avoid electric shock.
• Do not place the device or adapter where it can fall into a sink or tub.
• If the unit is dropped into water, unplug it immediately from the power outlet. Do not touch the water or liquid while the device is connected to power.
• Never use the device while in a bathtub or swimming pool.
• Keep the cord away from hot or heated surfaces such as radiators, stoves, or ovens.
• Do not use the device when your hair is wet. Towel dry your hair before use.
• Always attach the power supply to the unit first, then connect the plug into the electrical outlet.
• Use only the power adapter provided with the device.
• Do not operate the device if it has a damaged cord, plug, or helmet.
• Keep the lasers and device out of reach of children and pets.
• Always unplug the device from the power outlet before cleaning.
• Only use the device according to the instructions provided. Do not use it for any other purpose.
• Never attempt to repair the device on your own.
• Avoid dropping the device, as this may cause it to malfunction.
What components are included with the FREEDOM LASER THERAPY IRESTORE ID-500?
| Accessories | Quantity |
|---|---|
| iRestore ID-500 Laser Dome | 1 |
| Power Adapter | 1 |
| Remote Control | 1 |
| User Manual | 1 |
What are the main parts of the FREEDOM LASER THERAPY IRESTORE ID-500 and what are their functions?
| Description | Function |
|---|---|
| Laser Dome Housing | Plastic laser dome configured with 21 Class 3R lasers (<5mW) and 30 LEDs (660 ± 5nm) to provide low-level light therapy treatment to the scalp. |
| Stretcher Housing | Plastic headband that serves as a mounting base for the Laser Dome Housing. |
| Power Wire | Connects the device and remote control. |
| Remote Control | External system control center. Controls the built-in timer and the on/off switch of the light source. |
| Foam Pad | Padding around the protective shield to increase comfort. |
| Light Emitting Diode (LED) | 30 LEDs (660 ± 5nm) are the light source for treatment. |
| Laser Diode (Class 3R) | 21 lasers (<5mW) are the light source for treatment. |
| Safety Sensor | An electronic sensor that permits use of the iRestore only when it is placed on the head in the recommended position. |
How should I use the FREEDOM LASER THERAPY IRESTORE ID-500?
You should use the FREEDOM LASER THERAPY IRESTORE ID-500 for 25 minutes, every other day, on non-consecutive days. Use the iRestore for 16 weeks. Once the 16-week period is completed, use as frequently as needed to maintain the desired results without exceeding every other day for 25 minutes. Discontinuing use may result in the loss of hair.
Follow these steps for operation:
Step 1. Remove the device from the packaging. In its upright position, position the device on your head, ensuring the front portion does not cover your eyes.
Step 2. Insert the 5V AC power adapter pin into the wired controller.
Step 3. Plug the power adapter into an electrical outlet.
Step 4. Sit down and position the dome comfortably. Press POWER to turn on the device. (NOTE: If the START button is not pressed within one minute, the device will turn off automatically.)
Step 5. Press the START button to begin the 25-minute session. A short “beep” indicates the session has started. Once the session is complete, the device will turn off automatically with a long “beep” sound.
Step 6. If you need to pause the session, press the START button and the timer will flash. Press the START button again to resume the session. An audible “beep” will indicate the session has resumed. If the START button is not pressed within 5 minutes during a pause, the device will turn off automatically.
Step 7. To turn off the device, hold the POWER button for 3 seconds. Unplug the power adapter from the electrical outlet by pulling from the plug, not the cord.
IMPORTANT: The device will not begin a session unless it is positioned on the user’s head due to a safety sensor. If the device is removed from the head during a session, it will pause automatically. To resume, position the device on your head within 5 minutes and press the START button.
How do I clean the FREEDOM LASER THERAPY IRESTORE ID-500?
• The FREEDOM LASER THERAPY IRESTORE ID-500 should be unplugged prior to any cleaning.
• Use a dry microfiber cleaning wipe or cloth to clean the device.
• Do not use solvents to clean the device.
• For stains that cannot be removed with a dry cloth, a lightly water-moistened cloth may be used.
What are the storage instructions for the FREEDOM LASER THERAPY IRESTORE ID-500?
Keep the FREEDOM LASER THERAPY IRESTORE ID-500 away from sunlight and store it in a dry location (e.g., away from windows, sinks, bathtubs, kitchens, and bathrooms) at around room temperature after each use.
My FREEDOM LASER THERAPY IRESTORE ID-500 is powered on, but the lasers do not activate when I press START. What should I do?
The lasers and lights on your FREEDOM LASER THERAPY IRESTORE ID-500 will not power on unless the electronic sensor detects that the device is positioned on the user’s head. This is a built-in safety feature to protect the eyes from direct laser light exposure. Ensure the device is properly positioned on your head before pressing START.
My FREEDOM LASER THERAPY IRESTORE ID-500 is not powering on. What is the solution?
If your FREEDOM LASER THERAPY IRESTORE ID-500 is not powering on, please attempt to use another wall socket to plug the adapter into and try to turn it on again.
The remote for my FREEDOM LASER THERAPY IRESTORE ID-500 is on, but the helmet is not lighting up. What should I do?
If the remote control for your FREEDOM LASER THERAPY IRESTORE ID-500 is on but the main unit is not lighting up, you may need a replacement unit. Please contact the manufacturer for assistance.
The numbers on the timer of my FREEDOM LASER THERAPY IRESTORE ID-500 remote are not clear. What is the fix?
If the remote control for your FREEDOM LASER THERAPY IRESTORE ID-500 does not show the numbers clearly on the timer, you may need a replacement remote control. Please contact the manufacturer to request one.
Why doesn’t my FREEDOM LASER THERAPY IRESTORE ID-500 turn on immediately after I press the POWER button?
If your FREEDOM LASER THERAPY IRESTORE ID-500 doesn’t turn on right away, hold the POWER button for 3-5 seconds. This allows the device’s internal software to reset itself.
What are the product specifications for the FREEDOM LASER THERAPY IRESTORE ID-500?
| Item Number | ID-500, iRestore Laser Hair Growth System |
| Color | White |
| Wavelength | 640 – 665nm |
| Laser Power for Classification | <5mW, Laser Class 3R |
| Beam Diameter | Ø10mm at 10mm |
| Electrical Current | 950 ± 95mA |
| Beam Divergence | < 2mm |
| Net Weight | 1.34lbs |
| Size | 10.21 x 9.13 x 6.29 in. |
| Number of Lasers (5mW) | 21 |
| Number of LED (660 ± 5nm) | 30 |
| Power Adapter | Wellmike, Model: ADS012J-W 050240. (AC 100-240Vac), 50/60Hz, 0.5A DC 5V, 2.4A |
| Power Consumption | < 5.3W |
| Input | 100 – 240V |
| Operating environment Temperature | 41 °F – 104 °F |
| Operating environment Humidity | 15% – 85% RH |
| Operating environment Pressure | 700 hpa to 986 hpa |
| Storage & Transportation Temperature | 32 °F – 122 °F |
| Storage & Transportation Humidity | 10% – 95% RH |
| Electrical Safety Classification | Class II, Type BF, Applied Part LED & Laser. Not suitable for use in the presence of a flammable anesthetic mixture. Ip22: Enclose equipment without protection against ingress of water. Continuous operation. |
| Life Time | 5 Years |
What are the electromagnetic emissions and immunity declarations for the FREEDOM LASER THERAPY IRESTORE ID-500?
The FREEDOM LASER THERAPY IRESTORE ID-500 is compliant with IEC 60601-1-2. The following tables detail its electromagnetic declarations.
Declaration – electromagnetic emissions
| Emissions test | Compliance | Electromagnetic environment – guidance |
|---|---|---|
| CE emissions CISPR11 | Group 1 | The iRestore Laser Hair Growth System™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RE emissions CISPR11 | Class B | |
| Harmonic emissions IEC 61000-3-2 | Class A | The iRestore Laser Hair Growth System™ is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Voltage fluctuations/flicker emissions IEC 61000-3-3 | Complies |
Declaration – electromagnetic immunity
| Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment – guidance |
|---|---|---|---|
| Electrical discharge (ESD) IEC 61000-4-2 | ±6 kV contact ±8 kV air |
±6 kV contact ±8 kV air |
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical fast transient/burst IEC 61000-4-4 | ±2 kV for power supply lines ±1 kV for input/output lines |
±2 kV for power supply lines | Mains power quality should be that of a typical commercial or hospital environment. |
| Surge IEC 61000-4-5 | ±1 kV differential mode ±2 kV common mode |
±1 kV differential mode ±2 kV common mode |
Mains power quality should be that of a typical commercial or hospital environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | <5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycle 70 % UT (30 % dip in UT) for 25 cycle <5 % UT (>95 % dip in UT) for 5 sec |
<5 % UT (>95 % dip in UT) for 0.5 cycle 40 % UT (60 % dip in UT) for 5 cycle 70 % UT (30 % dip in UT) for 25 cycle <5 % UT (>95 % dip in UT) for 5 sec |
Mains power quality should be that of a typical commercial or hospital environment. If the user of the EQUIPMENT or SYSTEM requires continued operation during power mains interruptions, it is recommended that the EQUIPMENT or SYSTEM be powered from an uninterruptible power supply or a battery. |
| Power frequency(50/60 Hz) magnetic field IEC 61000-4-8 | 3 A/m | 3 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
What are the recommended separation distances between the FREEDOM LASER THERAPY IRESTORE ID-500 and RF communications equipment?
To prevent electromagnetic interference, a minimum distance should be maintained between portable and mobile RF communications equipment (transmitters) and the FREEDOM LASER THERAPY IRESTORE ID-500. The recommended separation distances are as follows:
| Rated maximum output power of transmitter (W) | Separation distance according to frequency of transmitter (M) | ||
|---|---|---|---|
| 150 kHz to 80 MHz d=1.2√P |
80 MHz to 800 MHz d=1.2√P |
800 MHz to 2.5 GHz d=2.3√P |
|
| 0.01 | 1.2 | 0.12 | 0.23 |
| 0.1 | 3.8 | 0.38 | 0.73 |
| 1 | 12 | 1.2 | 2.3 |
| 10 | 38 | 3.8 | 7.3 |
| 100 | 120 | 12 | 23 |
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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